Three-Dimensional Quantitative Assessment of Pedicle Screw Accuracy in Clinical Utilization of a New Robotic System in Spine Surgery: A Multicenter Study.

OBJECTIVE: The objective of this study was to evaluate the accuracy of pedicle screw placement in patients undergoing percutaneous pedicle screw fixation with robotic guidance, using a newly developed 3-dimensional quantitative measurement system. The study also aimed to assess the clinical feasibility of the robotic system in the field of spinal surgery. METHODS: A total of 113 patients underwent pedicle screw insertion using the CUVIS-spine pedicle screw guide system (CUREXO Inc.). Intraoperative O-arm images were obtained, and screw insertion pathways were planned accordingly. Image registration was performed using paired-point registration and iterative closest point methods. The accuracy of the robotic-guided pedicle screw insertion was assessed using 3-dimensional offset calculation and the Gertzbein-Robbins system (GRS). RESULTS: A total of 448 screws were inserted in the 113 patients. The image registration success rate was 95.16%. The average error of entry offset was 2.86 mm, target offset was 2.48 mm, depth offset was 1.99 mm, and angular offset was 3.07°. According to the GRS grading system, 88.39% of the screws were classified as grade A, 9.60% as grade B, 1.56% as grade C, 0.22% as grade D, and 0.22% as grade E. Clinically acceptable screws (GRS grade A or B) accounted for 97.54% of the total, with no reported neurologic complications. CONCLUSION: Our study demonstrated that pedicle screw insertion using the novel robot-assisted navigation method is both accurate and safe. Further prospective studies are necessary to explore the potential benefits of this robot-assisted technique in comparison to conventional approaches.

Novel C-arm-based planning robotic spinal surgery in a cadaver model using quantitative accuracy assessment methodology.

BACKGROUND: This preclinical study emulating the clinical environment quantitatively analysed the accuracy of pedicle screw insertion using a navigated robotic system. METHODS: Pedicle screws were placed from T7 to L5 in the whole-body form of a cadaver. After the insertion of multiple artificial markers into each vertebra, errors between the planned insertion path and the inserted screw were quantified using the Gertzbein-Robbins system (GRS) and offset calculation. RESULTS: A total of 22 screws were placed. Almost all (95.45% [21/22]) were classified as GRS A or B, while one (4.55%) was GRS C. The mean and standard deviations of entry, tip, and angular offset were 1.78 ± 0.94 mm, 2.30 ± 1.01 mm, and 2.64 ± 1.05°, respectively. CONCLUSIONS: This study demonstrated that pedicle screw insertion using a navigated robotic system had high accuracy and safety. A future clinical study is necessary to validate our findings.